Drug-eluting stents were devised as an answer to restenosis, but research has shown that the eluting
drug can interfere with the blood vessel's healing process, thus increasing the risk of
stent thrombosis. A
stent coated with the new proprietary
polymer Polyzene-F, is a novel technical
solution that promises to decrease in-
stent restenosis and tackle the risk of
thrombosis. Fifty-five patients were enrolled in the first clinical human study (ATLANTA registry), addressing the short-term follow-up results of the CATANIA
stent with
Polyzene-F. As a part of the study protocol, 15 patients were randomly assigned to optical coherence tomographic (OCT) examination at 6-month follow-up. Optical coherence tomograms were obtained using a Lightlab M2 system with a motorized pull-back at 2.0 mm/s. OCT images were acquired at 15.6 frames/s. A total of 1,904 cross-sectional images with 19,028 struts were analyzed. The rate of covered struts was 99.5%, whereas malapposed struts accounted for 0.15%. Area measurements were performed in 476 cross sections. Neointimal
hyperplasia (NIH) area and percent NIH area were 3.2 +/- 1.4 mm2 and 38 +/- 17%, respectively. Percent NIH area was comparable between diabetics and nondiabetics. Qualitative assessment of OCT images demonstrated neither occurrence of
stent fractures nor
thrombus. In conclusion, OCT assessment of the
Polyzene-F-covered
stent at follow-up showed a small percentage of
neointima. Also, almost complete
stent strut coverage was revealed by optical coherence tomography. These figures indicate that the CATANIA
stent with
Polyzene-F is a promising
solution for decreasing late
stent restenosis and preventing
thrombosis.